What Are Pharmaceutical and Biotechnology Facilities?
Pharmaceutical quality forms the critical foundation for ensuring the safety and efficacy of drugs and medications. It builds confidence and trust among users and patients to follow the prescribed drug recommendations regularly. Optimally designed, fully operating pharmaceutical and biotechnology facilities are essential for producing superior-quality pharmaceutical products. This article briefs basic design layouts needed for drug manufacturing and also navigates through certain operational procedures followed by pharmaceutical and biotechnology facilities in drug development.
What Is the Difference Between Pharmaceutical and Biotechnology Facilities?
Although both pharmaceutical and biotechnology facilities manufacture medicines, it is essential to know the common similarities and differences between pharmaceutical and biotechnology facilities, for it would help in understanding their functioning and role in drug development and manufacturing processes.
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Pharmaceutical Facilities - These facilities synthesize medicines that are of chemical origin. The key ingredients are chemicals that undergo synthetic processing and get converted into drugs (for example, Paracetamol and Pantoprazole.) and other pharmaceutical products (reagents).
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Biotechnology Facilities - Products manufactured by these facilities are primarily derivatives of living organisms. Components from living cells are extracted and processed into medicines (for example, COVID-19 vaccines and monoclonal antibody preparations like Amivantamab-view). Biotechnology facilities that exclusively produce therapeutic antibodies, vaccines, nucleic acids, and plasma products are termed biopharmaceutical companies.
How to Design Pharmaceutical and Biotechnology Facilities?
Designing any pharmaceutical facility focuses on the final drug product delivered. While planning a design layout for a pharmaceutical or biotechnology facility, the following features are mandatory and need to be incorporated.
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The building must be convenient for the operators to promote easy production.
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It should establish an uninterrupted workflow pathway, minimize bioburden, and enforce compliance with governing laws, specific codes, and proposed regulations by the Food and Drug Administration (FDA).
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Room classifications (for autoclaves, raw material storage units, water systems, and depyrogenation ovens) and segregation protocols should be introduced to prevent contamination and chemical leakage accidents.
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GMP (good manufacturing practice) guidelines must be precisely followed to ensure environmental safety and health.
Various techniques and planning strategies employed in designing and developing pharmaceutical and biotechnology facilities are as follows:
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Master Planning of Site - Site master plans focus on the cost-effectiveness of manufacturing facilities. It helps in reducing operating expenditures. Convenient sites are selected for overall as well as future development of facilities.
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Manufacturing Process Designing - Methodical pharmaceutical steps such as batch process, thermodynamics, fluid mechanics, and kinetics are analyzed, and alternative techniques for processing are identified.
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Modeling of Process and Simulation - Computer models refine the available process. Conceptual designs are transformed into operational designs. Utility and debottlenecking analyses are carried out to increase productivity.
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Risk Analysis - Risks associated with budgeting (production costs) and schedule handling (marketing of final products) are analyzed. Potential risk impact areas are identified, and manufacturing processes are modified accordingly.
How Are Pharmaceutical and Biotechnology Facilities Operated?
Pharmaceutical and biotechnology facilities operate on multi-level strategies, which include a flow of products and personnel, spill removal, cleaning facilities, equipment handling, and maintenance. Some of the basic operating steps are as follows:
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Handling of Materials - Substances like granules, powders, capsules, and tablets are moved through various stages of the manufacturing process.
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IBCs (intermediate bulk containers) are preferred to move products between operating processes. These are widely employed in oral solid dosage (OSD) pharmaceutical facilities.
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Single-Floor Operating Facilities - IBCs are used to transfer full batches in single-floor systems, where the wastage of products is reduced. Vertical transfer units fed by gravity are also employed using mezzanines or frameworks.
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Drug Processing - Excipients (non-active ingredients) and active therapeutic ingredients are blended according to the distribution of particle size, flow properties, and surface characteristics such as cohesion and roughness.
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Other manufacturing operations include milling (reducing particle size), dry or wet granulation (converted to larger particles), tablet pressing, and film coating.
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Drugs with poor bioavailability or reduced solubility undergo hot melt extrusion processing, where molecular carriers are added.
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Double Floor Facilities - These are mainly processing units where the ingredients are blended (top floor), pressed into tablets, or filled into capsules (lower floor), and undergo quality control checks formulated by the FDA (the United States Food and Drug Administration). This is one of the important steps in GMP guidelines to prevent potential contamination and maintain superior quality.
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Multi-Level Operating Facilities - Establishing multiple floor operating facilities is expensive but flexible, involving enormous operational space. These operating processes are widely used in biopharmaceutical manufacturing facilities where additional operating units like cell culture labs, molecular biology laboratories, and different levels of biosafety cabinets (BSCs) are employed for handling living cells, tissues, viral vectors, and microorganisms.
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Safety Equipment - Since pharmaceutical chemicals are potentially hazardous, the availability of safety equipment is mandatory in drug manufacturing units. Safety showers and eyewashes should be used if contact with corrosive and irritating materials occurs. Insulation installation is employed to protect the workers from potential electrical hazards.
What Are the Recent Trends in Designing and Operating Pharmaceutical and Biotechnology Facilities?
Over the recent years, pharmaceutical and biotechnology facilities have grown exponentially, and numerous factors have been incorporated to transform the existing facilities or build new facilities to increase production rates, reduce operational costs, and enhance product quality. Some of the latest innovations seen in designing and operating pharmaceutical and biotechnology facilities are as follows -
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Modular Facilities - These are pre-engineered manufacturing units that optimize capital expenditure and reduce construction timelines.
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Provided with built-in manufacturing equipment, modular facilities favor reconfiguration and upgradation of equipment.
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Single-Use Systems (SUS) - These units are more convenient and compliant, particularly when renovating existing facilities is impossible. They are widely preferred in biopharmaceutical facilities where the demand for the final product is high with a limited timeframe for production.
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Manufacturing COVID-19 vaccines and new therapies involving cell and recombinant DNA technology have contributed to using SUS technologies.
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Renovation of Facilities - This involves the demolition of already existing units, followed by the installation of upgraded equipment. For example, in the production of Belimumab, an injectable monoclonal antibody, laboratories were updated, and single-use bioreactors were installed.
Conclusion
Pharmaceutical and biotechnology facilities are manufacturing units involved in the development and production of drugs. Good design and effective operation of these facilities result in the production and free flow of essential medications into the community. Also, they enhance the reliability of pharmaceutical products and their use by the general population.
